Medical and Regulatory Affairs

Clinical Research: Phase 1 - Phase 4

Understanding Recent Regulatory Changes for Pediatric Oncology Trials

Of the 1.7 million new cases of cancer in the U.S. in 2018, 10,590 involved children aged 14 or younger.[1] While children typically have a better cure rate for cancer, biopharma companies have traditionally shied away from pediatric oncology trials, resulting in fewer treatment options. However, the regulatory landscape is evolving, and the demand for...

Clinical Research: Phase 1 - Phase 4

Considerations In Conducting Pediatric Clinical Trials

There are many challenges inherent in pediatric clinical studies, where the traditional paradigms for evaluating pharmaceutical agents in adults often do not apply. These occur on ethical, physiological, pharmacometrics and economic grounds, among many others. It’s important to recognize that while these efforts are challenging, they are not impossible — and they may be better suited to creative solutions...

Clinical Research: Phase 1 - Phase 4

Neurodegenerative Disease Research: Steps to a Successful Clinical Trial

Neurodegenerative disorders present some of the biggest challenges in planning and conducting clinical drug trials. Diagnosis is challenging, given the often-delayed onset and diversity of symptoms. Operational challenges associated with clinical trial development complicate things even further. Identifying strategies to proactively address or mitigate these challenges can help to ensure a successful trial.

Consulting

Strategic Planning for Compliance with the EU Medical Device Regulation

The changes are significant. Here’s what you must know. Makers of medical devices must build compliance into product development to comply with the EU Medical Device Regulation (MDR). Our white paper looks at key rule changes under the MDR, such as an expanded definition of what constitutes a medical device, the increased need for clinical...

Consulting

Best Practices For Interventional Cardiovascular Medical Device Trials In APAC

The Asia-Pacific region (APAC) is prepared to be key in addressing one of the word’s great health concerns. In our aging society, heart disease has become one of the most significant health problems worldwide. Its incidence is forecast to increase steadily as the number of people aged 60 and older is expected to double by...

Medical and Regulatory Affairs

The Role Of Notified Bodies Under The EU Medical Devices Regulation

The EU Medical Devices Regulation (MDR) was published on May 5, 2017. The impetus behind these new, more rigorous regulations was in part to reflect the substantial technological and scientific advances made by the medical device sector and in part a response to the need for regulations that would significantly tighten the controls around medical...

Consulting

In the Spotlight: Recent FDA Updates and Guidance for Rare Disease Drug Development

The US Food and Drug Administration (FDA) just updated its 2015 draft guidelines for drug discovery in rare diseases. The January update, Rare Diseases: Common Issues in Drug Development, seeks to help pharmaceutical companies and other sponsors perform more efficient development programs for drugs and biological products and provides new insights on complex elements of...

Consulting

A Security Plan for All Stakeholders Involved in Digital Medicine: What Device Manufacturers Need to Know

Connected medical devices, like all other computer systems, are vulnerable to threats that may lead to compromise of data confidentiality, integrity, and availability. To address these challenges, the Healthcare and Public Health Sector Coordinating Council (HSCC) Joint Cybersecurity Working Group recently issued the Medical Device and Health Information Technology (IT) Joint Security Plan (JSP). [1]...

Clinical Research: Phase 1 - Phase 4

Principles Of CAR T Cell Therapy And The Pathway To Regulatory Approval

For many years, the primary forms of cancer treatment have been chemotherapy, radiation and surgery, but the toughest forms of cancer demand breakthrough therapies. Advances in immuno-oncology have led to the advent of Chimeric Antigen Receptor T (CAR T) cell therapy, which combines a patient’s own T cells with engineered T cell receptors known as...

Global Compliance

Strategic Planning for Compliance With the EU Medical Device Regulation

Compliance with the EU Medical Devices Regulation (MDR) is a significant undertaking that requires cross-functional collaboration. In this post, we explore key activities involved in strategic planning for compliance. Establishing a leadership team Good leadership is essential for managing the transition to EU MDR compliance and creating an execution strategy which includes timelines and mechanisms...